CTRI/2010/091/000312Other3 期
A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multiple-Site Study to Evaluate the Clinical Equivalence of Two Generic Butenafine Hydrochloride 1% creams to Lotrimin Ultra® cream in Patients with Interdigital Tinea Pedis
Taro Pharmaceuticals USA, Inc. 3 Skyline Drive Hawthorne, NY 10532 (914)345-90010 个研究点目标入组 1,600 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- Other
- 发起方
- 入组人数
- 1,600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Males and femalepatients with age 18 years of age or older.
- •2. Signed informed consent form, which meets all criteria of current DCGI and FDA regulations.
- •3. If female and of child bearing potential, has a negative urine pregnancy test at the baseline visit
- •4. A total score of at least six (6) for the following eight (8) clinical signs and symptoms of interdigital tinea pedis: fissuring, erythema, maceration, vesiculation, desquamation/scaling, exudation, pruritus, burning/stinging. In addition the most infected area must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for either pruritus or desquamation/scaling.
- •5. A confirmed clinical diagnosis of interdigital tinea pedis.
- •6. The presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic KOH wet mount examination and fungal culture test
排除标准
- •1. Use of any of the following within the indicated timeline:
- •# Oral or injectable steroids within four weeks of the study start.
- •# Any oral anti-fungals within 4 weeks of the study start
- •# Use of topical corticosteroids or any other topical antipruritics on the feet within 72 hours of the study start.
- •# Any prescription or OTC topical antifungals on the feet within two weeks prior to study entry
- •# Use of any antihistamines within 72 hours of the study start.
- •2. Any known hypersensitivity to butenafine or other antifungal agents.
- •3. Females who are pregnant, lactating or likely to become pregnant during the study.
- •4. Significant history or current evidence of chronic infectious disease, system disorder, organ disorder or other medical condition,
- •5. Evidence of any concurrent dermatophytic infection of toe nails (onychomycosis) or other dermatological condition
- •6. Patients with recurrent tinea pedis
- •7. Noncompliance of protocol
- •8. Receipt of any drug as part of a research study.
研究者
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